Search Results for: ESH: nuove linee guida complete per la gestione dell’ipertensione arteriosa

Introduction
Distal radius fractures account for one-fifth of all fractures in the active elderly population and may cause chronic pain, loss of hand function and reduced work productivity, imposing a significant socioeconomic burden. Most are initially treated with closed reduction and casting, but 30% subsequently require surgery due to insufficient realignment. The current approaches for analgesia for closed reduction are suboptimal. A brachial plexus nerve block provides complete pain relief and muscle relaxation distal to the elbow, potentially creating better conditions for realignment of the fractured bone ends. This may ultimately translate into reduced need for surgery and result in better functional outcomes and fewer complications compared to a haematoma block, which is the current standard care in Denmark.

Methods and analysis
The BLOCK Trial is an investigator-initiated, parallel-group, allocation-concealed, outcome assessor and analyst-blinded, superiority, randomised, controlled, clinical multicentre trial performed at 11 Danish emergency departments. Eligible adult patients with a distal radius fracture who need closed reduction will be included and allocated 1:1 to either an ultrasound-guided brachial plexus nerve block or a haematoma block. The primary outcome is the proportion of patients with distal radius fracture surgery 90 days after closed reduction. We will include 1716 participants to detect or discard a relative risk reduction of surgery of 20%. Secondary outcomes include treatment-related complications, patient-reported wrist function, pain during closed reduction and proportion of patients with unacceptable radiographic fracture position immediately after closed reduction.

Ethics and disseminationf
The trial is approved by the Danish Medicines Agency and the Danish Research Ethics Committees (EU CT number: 2024-512191-35-00). All results will be summarised on www.theblocktrial.com, clinicaltrials.gov and euclinicaltrials.eu after publication. Primary and secondary outcome results from 0 to 90 days will be presented in the main article and submitted to a peer-reviewed journal. Results from outcomes on the 12-month follow-up will be presented separately.

Trial registration number
NCT06678438.

In children with SBS, longer residual small bowel, better nutritional status and absence of liver disease were associated with response to teduglutide. Complete PN weaning was predicted by lower calories needs and higher citrulline at baseline. An increase of haemoglobin and citrulline in the first 6 months of treatment were further predictors of complete PN weaning. Even if limited by the real-life design of the study, these findings may guide a tailored indication for the use of teduglutide in children with short bowel syndrome.

Introduction
Social media sites are increasingly used to assess and treat different mental health problems in adolescents and young adults. However, it is still unclear which social network sites are the most used for this purpose and what interventions for tackling unhealthy body image have been validated. This systematic review will assess evidence on the effectiveness of social media interventions in improving unhealthy body image among adolescents and young adults.

Methods and analysis
Five databases, including Embase, Scopus, MEDLINE, Web of Science (Core Collection) and PsycINFO, will be consulted, with a publication window starting in 2011 and ending on 31 October 2024. Rayyan software will detect and eliminate duplicates. We will include only studies based on social media-based interventions for adolescents and young adults with body image problems. Two independent reviewers will screen titles, abstracts and full-text articles, resolving conflicts through discussion with a third reviewer as needed. The two reviewers will complete the risk of bias assessments for each included study, using the Joanna Briggs Institute critical appraisal checklists for randomised controlled trials and quasi-experimental studies. We will report on the characteristics of studies, participants and interventions in descriptive narrative form, along with the results from the assessment of social media interventions.

Ethics and dissemination
Universidad Cesar Vallejo’s ethics committee approved this systematic review protocol as part of a wider project (code 100-CEI-EPM-UCV-2022). Results will be shared via social media to engage stakeholders and promote awareness of body image issues.

A Palidoro, struttura continuerà a offrire accoglienza famiglie

Objectives
Diabetes mellitus (DM) affects over 422 million individuals globally. Diabetic foot ulcers (DFUs) stand out as a challenging complication of DM, affecting up to 34% of individuals with DM. Despite the prevalence of DFUs, clinical trials for DFUs often face slow and insufficient patient recruitment. We aimed to identify key determinants that impact subject recruitment rates in DFU clinical trials.

Design
Systematic review.

Data sources
ClinicalTrials.gov and PubMed were searched to identify DFU clinical studies published from 1 January 1990 to 9 April 2025.

Eligibility criteria
We included English-language publications of clinical trials aimed at healing DFUs that reported enrolment numbers, duration of enrolment and number of study centres.

Data extraction and synthesis
Records were extracted and subjected to two independent rounds of review by five authors (LZ, SP, RN, HL-T, and RK). Data were pooled and analysed using negative binomial regression, Kaplan-Meier methods and Cox proportional hazards models. Study enrolment and site enrolment rates, as well as time to complete study enrolment, were analysed. Between-study heterogeneity was assessed using the likelihood ratio test.

Results
397 trials involving 31 955 participants were included. On average, DFU studies enrolled 4.24 patients per month (median: 1.65). US-based studies had slower recruitment than non-US studies, with a mean enrolment rate of 1.51 patients per site per month (median: 0.58). The average time to complete enrolment was 1.28 years. Studies that employed a higher number of study sites, were conducted outside the USA, studied behavioural or dietary supplement interventions, and began enrolment more recently, were more likely to have a higher enrolment rate. Longer time to complete enrolment was associated with a larger number of study sites, trials involving at least one US site, earlier starting enrolment year, and longer follow-up duration.

Conclusions
These findings have potential practical implications for the design and conduct of future DFU trials.

Introduction
Urban green and blue space (UGBS) interventions, such as the development of an urban greenway, have the potential to provide public health benefits and multiple co-benefits in the realms of the environment, economy and society. This paper presents the protocol for a 5-year follow-up evaluation of the public health benefits and co-benefits of an urban greenway in Belfast, UK.

Methods and analysis
The natural experiment evaluation uses a range of systems-oriented and mixed-method approaches. First, using group model building methods, we codeveloped a causal loop diagram with stakeholders to inform the evaluation framework. We will use other systems methods including viable systems modelling and soft systems methodology to understand the context of the system (ie, the intervention) and the stakeholders involved in the development, implementation and maintenance phases. The effectiveness evaluation includes a repeat cross-sectional household survey with a random sample of 1200 local residents (adults aged ≥16 years old) who live within 1 mile of the greenway. The survey is complemented with administrative data from the National Health Service. For the household survey, outcomes include physical activity, mental well-being, quality of life, social capital, perceptions of environment and biodiversity. From the administrative data, outcomes include prescription medications for a range of non-communicable diseases such as cardiovascular disease, type II diabetes mellitus, chronic respiratory and mental health conditions. We also investigate changes in infectious disease rates, including COVID-19, and maternal and child health outcomes such as birth weight and gestational diabetes. A range of economic evaluation methods, including a cost-effectiveness analysis and social return on investment (SROI), will be employed. Findings from the household survey and administrative data analysis will be further explored in focus groups with a subsample of those who complete the household survey and the local community to explore possible mechanistic pathways and other impacts beyond those measured. Process evaluation methods include intercept surveys and direct observation of the number and type of greenway visitors using the Systems for Observing Play and Recreation in Communities tool. Finally, we will use methods such as weight of evidence, simulation and group model building, each embedding participatory engagement with stakeholders to help us interpret, triangulate and synthesise the findings.

Ethics and dissemination
To our knowledge, this is one of the first natural experiments with a 5-year follow-up evaluation of an UGBS intervention. The findings will help inform future policy and practice on UGBS interventions intended to bring a range of public health benefits and co-benefits. Ethics approval was obtained from the Medicine, Health and Life Sciences Research Ethics Committee prior to the commencement of the study. All participants in the household survey and focus group workshops will provide written informed consent before taking part in the study. Findings will be reported to (1) participants and stakeholders; (2) funding bodies supporting the research; (3) local, regional and national governments to inform policy; (4) presented at local, national and international conferences and (5) disseminated by peer-review publications.

Introduction
There is a need for early, non-invasive and inexpensive biomarkers for Alzheimer’s disease (AD), which could serve as a proxy measure in prevention and intervention trials that might eventually be suitable for mass screening. People with Down syndrome (DS) are the largest patient group whose condition is associated with a genetically determined increased risk of AD. The REVEAL study aims to examine changes in the structure and function of the eye in individuals with DS compared with those with mild cognitive impairment (MCI) and cognitively healthy control (HC) individuals. REVEAL will also explore whether these changes are connected to inflammatory markers previously associated with AD.

Methods and analysis
The protocol describes a cross-sectional, non-interventional, single-centre study recruiting three cohorts, including (1) participants with DS (target n=50; age range, 6–60 years), (2) participants with MCI (target n=50; age range, 50–80 years) and (3) HC participants (target n=50; age range, 50–80 years). The primary research objective is to profile retinal, choroidal and lenticular status using a variety of eye imaging modalities and retinal functional testing to determine potential associations with cognitive status. The REVEAL study will also measure and compare established blood markers for AD and proteomic and transcriptomic marker profiles between DS, MCI and HC groups. Between-group differences will be assessed with an independent sample t-test and 2 tests for normally distributed or binary measures, respectively. Multivariate regression analysis will be used to analyse parameters across all three cohorts. Data collection began in October 2023 and is expected to end in October 2025.

Ethics and dissemination
The study gained a favourable opinion from Health and Social Care Research Ethics Committee A (REC reference 22/NI/0158; approved on 2 December 2022; Amendment 22/0064 Amend 1, 5 April 2023; Amendment 22/0064 Amend 2; 23 May 2024; Amendment 22/0064 Amend 3; 25 June 2024; Amendment 22/0064 Amend 4; 16 January 2025; Amendment 22.0064 Amend 5; 9 May 2025; Amendment 22.0064 Amend 6; 9 June 2025). The study has also been reviewed and approved by the School of Biomedical Sciences Research Ethics Filter Committee within Ulster University. Findings from the REVEAL study will be presented to academic audiences at international conferences and peer-reviewed publications in targeted high-impact journals after data collection and analysis are complete. Dissemination activities will also include presentations at public events.

Introduction
Severe perinatal asphyxia at term or near term remains a critical public health issue, associated with high risks of neonatal death and hypoxic-ischaemic encephalopathy (HIE). Despite improved clinical guidelines, suboptimal care persists in many cases, and previous audits have demonstrated that up to 50% of asphyxia cases could be associated with suboptimal care. OptiNeoCare is a French study which aims to assess the prevalence and determinants of suboptimal obstetric and neonatal care and evaluate its potential impact on neonatal outcomes.

Materials and methods
This prospective, population-based observational study will include newborns ≥36 weeks’ gestation with severe perinatal asphyxia across 12 French perinatal networks (213 maternity units). Inclusion criteria comprise neonatal death or moderate/severe HIE with confirmed biochemical markers of asphyxia. Data will be collected prospectively from labour wards, transport teams and neonatal intensive care units using an electronic case report form, and the in-situ team will be invited to complete a morbi-mortality review (MMR). Approximately 336 cases will be included over 12 months, with 25% randomly selected for confidential enquiry by two experts. The quality of care will be assessed based on a structured classification of medical errors (diagnostic, therapeutic, preventive and systemic) by a panel of experts including an obstetrician or midwife and a paediatrician. Root cause analysis will identify determinants of suboptimal care. A concordance analysis will compare findings from MMRs and confidential enquiries. Statistical analysis will include multivariable logistic regression to explore associations between care quality and neonatal outcomes.

Ethics and dissemination
Ethical approval was granted by the Ethics Committee for Research in Obstetrics and Gynaecology. Informed non-opposition is required from participants. Results will be shared with participating centres, healthcare professionals and through scientific dissemination.

Trial registration number
ClinicalTrials.gov ID: NCT06322732.

Aifa, attenzione a quelli per ansia e ipertensione

Introduction
Social accountability is a key value and aspirational goal of many medical institutions. While much has been studied on social accountability in the context of medical education and institutions, less research has examined how social accountability influences research. In light of this absence, the objective of our scoping review is to research the following questions: (1) What characterises socially accountable research (SAR), and how is it expressed and experienced? (2) How do language, positionality, and worldview influence SAR?, and (3) What structures and considerations are necessary to support successful SAR in local and global contexts?

Methods and analysis
To answer the above research questions, the Arksey and O’Malley, Levac et al, Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews and Joanna Briggs Institute (JBI) guidelines will be followed. The search strategy was adapted and applied to MEDLINE, Embase, ERIC, and CINAHL databases. A total of n=5289 eligible articles were identified. Articles were excluded if they were published before 1995, were in a language other than English, or were duplicates, leaving n=2840 articles for title/abstract screening.

Ethics and dissemination
Ethical approval is not required to complete this study. We will take an integrated knowledge translation approach. Throughout the project, results will be disseminated to knowledge users (ie, consultations, following Arksey and O’Malley). Our findings will be presented to the larger academic community, policymakers, and healthcare practitioners through presentations, reports, newsletters, and an online repository.

Trial registration number
Open Science Framework 16 July 2024. osf.io/mvhnu.

Introduction
Cardiovascular disease (CVD) represents a public health burden, with high prevalence and significant morbidity and mortality. Although evidence-based interventions exist, there is a need for more individualised care. The European project Individualised care from early risk of cardiovascular disease to established heart failure (iCARE4CVD) aims to personalise CVD prevention and treatment. Participatory health research, which actively involves patients in the planning, implementation and evaluation of projects, plays a crucial role here. However, patient participation is often unsuccessful due to the lack of a representative patient sample who is involved throughout the project’s duration, has knowledge of the project and can contribute their experience.

Methods and analysis
Participative Research for Individualised Care in Cardiovascular Diseases is a non-interventional, non-randomised, multicentre mixed-methods study. The aim is to incorporate patients’ insights into several key activities within iCARE4CVD by establishing country-specific patient panels in Belgium, Germany, Ireland and the UK. The primary objective is to identify patients’ preferences, experiences, requirements and needs for better diagnosis, treatment and self-care of CVD. Therefore, 10–12 patients across the CVD spectrum, from early risk to established CVD and heart failure, will be included in each country (40–48 in total). Over 3.5 years, patient panel members are required to complete four tasks: (1) identification of meaningful Patient-Reported Outcome and Experiences Measures, (2) development of a motivational model to increase adherence, (3) feedback on CVD care processes and (4) usability testing of new digital tools developed within iCARE4CVD. These tasks comprise eight activities in the form of paper-based or digital exercises, telephone surveys, written surveys and in-person focus groups. The results will be continuously incorporated into iCARE4CVD.

Ethics and dissemination
This study received ethical approval by the Ethics Committee at the Faculty of Medicine of RWTH Aachen University (EK 24-172) and St. Vincent’s University Hospital (RS24-027), Research Ethics Committee. In Geel and Belfast, positive ethics approval is pending. All participants will provide written informed consent prior to enrolment in the study and participation in the first patient panel task. Results will be published in peer-reviewed journals and presented at scientific conferences.

Trial registration number
DRKS00034899.

Protocol version
V2.1, 6 June 2024.

Introduction
Understanding the prognostic factors associated with the failure of total elbow replacement (TER) is crucial for informing patients about risks and enabling shared decision-making regarding TER as a definitive management option. This protocol outlines the planned analysis of National Joint Registry (NJR) data to investigate prognostic factors for TER failure.

Methods and analysis
The primary analysis will use the NJR elbow dataset, including all eligible patients who underwent TER surgery between April 2012 and December 2023. To incorporate ethnicity and comorbidities as potential prognostic factors, the NJR will be linked to the National Health Service (NHS) England Hospital Episode Statistics-Admitted Patient Care (HES-APC) data for a secondary analysis. The analysis will adhere to the REporting recommendations for tumour MARKer prognostic studies guidelines. The primary outcome under investigation is TER failure, defined as requiring revision surgery. Initially, the overall prognosis of TER will be examined using unadjusted net implant failure via the Kaplan-Meier method. The list of potential prognostic factors to be investigated in this study has been informed by a systematic review on this topic, input from patient and public involvement and engagement (PPIE) groups and a survey shared with healthcare professionals providing TER services. The relationship between each potential prognostic factor and failure will be assessed using univariable regression methods. Based on the findings from our systematic review, the univariable association will also be adjusted for age, sex and indication for TER surgery using multivariable regression methods. The extent of missing data will be reported, and the reasons for missing data will be explored. A very high degree of data completeness is expected, and a complete case analysis will be performed as the primary analysis. Multiple imputations will be considered as a sensitivity analysis.

Ethics and dissemination
The NJR research committee approved this analysis, and the NHS Health Research Authority tool guidance dictates that the secondary use of such data for research does not require approval from a research ethics committee. The results from this analysis will be published in a peer-reviewed journal and presented at scientific conferences.

Trial registration number
NCT06760585.

Ricerca Università di Padova, Cnr e Istituto Mario Negri

La guida dell’Istituto sui cibi e le regole da rispettare

Buzzetti su glifozine,semplificazione e riduzione diseguaglianze